Cleared Traditional

K960021 - CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS

K960021 is an FDA 510(k) clearance for CALCITEK HA-COATED ENDOSSEOUS DENTAL IM..., manufactured by Calcitek, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K960021 · Calcitek, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
37d
Days
Class 2
Risk

K960021 is an FDA 510(k) clearance for the CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Calcitek, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 8, 1996 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Calcitek, Inc. devices

FDA 510(k) Submission Details - K960021

510(k) Number K960021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1996
Decision Date February 08, 1996
Days to Decision 37 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 127d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1287
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K960021.
3I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING IMPLANTS
K955427 · Implant Innovations, Inc. · Feb 1996
INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM
K943604 · Calcitek, Inc. · Feb 1996
3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS
K955428 · Implant Innovations, Inc. · Feb 1996
INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT
K955492 · Interpore Intl. · Jan 1996
ABUTMENT RETRIEVAL KIT
K955697 · Nobelpharma USA, Inc. · Jan 1996
BALL ATTACHMENT SYSTEM
K955372 · Nobelpharma USA, Inc. · Jan 1996